This phase I trial investigates the side effects and best dose of pulsed low-dose-rate radiation (PLDR) in treating patients with pancreatic cancer. During PLDR, radiation delivered is broken into pulses over a relatively longer period of time. Undergoing PLDR may create a more favorable environment for tumor shrinkage with fewer side effects and less damage to surrounding vital organs compared to conventional radiation therapy. It also may make surgery a more likely option in patients who are not otherwise good candidates for surgery to remove the tumor.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04452357.
PRIMARY OBJECTIVE:
I. To determine the safety of dose-escalated radiation, with PLDR technique, in the treatment of pancreatic cancer.
SECONDARY OBJECTIVES:
I. To assess the feasibility of surgery after PLDR radiation.
II. To develop a preliminary estimate of the efficacy of the investigational treatment.
III. To determine whether it is possible to assess the impact of PLDR radiation on pancreatic stroma and extracellular vesicles (EVs) in human patient samples in order to confirm preclinical findings.
OUTLINE: This is a dose-escalation study of PLDR.
Patients receive standard of care gemcitabine intravenously (IV) over 30 minutes on days 1, 8, and 15 prior to undergoing PLDR. Patients then undergo PLDR radiation consisting of either intensity-modulated radiation therapy (IMRT) or volume modulated arc therapy (VMAT) once every 3 minutes for 10 fractions (for a total of 28-33 fractions depending on dose level) 5 days weekly (Monday-Friday) over 6-7 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, every 6 months for 2 years, then annually thereafter.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorJoshua E. Meyer